A Phase I Trial of a Trivalent Vaccine with Escalating Doses of the Immunological Adjuvant OPT-821 Plus Oral ß-Glucan for High-Risk Neuroblastoma

The purpose of this study is to find the highest dose of a vaccine adjuvant called OPT-821 that can be given as part of a vaccine designed to treat neuroblastoma. The vaccine in this study targets three markers on neuroblastoma cells. The aim of the vaccine is to trigger a response of the immune system against neuroblastoma by causing the patient’s body to make antibodies against these markers which would, in turn, cause white blood cells to find and attack the cancer cells.

Other substances called adjuvants are added to cancer vaccines to boost the immune response against cancer cells. OPT-821 and KLH are the two adjuvants in this vaccine. OPT-821 is another version of adjuvant QS-21 which has been used in the past but is no longer available. Investigators want to see what dose of OPT-821 can be safely given in children. Patients will also take by mouth ß-glucan, a yeast sugar that can help white blood cells kill cancer cells.

blood (blud)

A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

cancer (KAN-ser)

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

dose (dose)

The amount of medicine taken, or radiation given, at one time.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

immune function (ih-MYOON FUNK-shun)

Production and action of cells that fight disease or infection.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

immune response (ih-MYOON reh-SPONTS)

The activity of the immune system against foreign substances (antigens).

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

immune system (ih-MYOON SIS-tem)

The complex group of organs and cells that defends the body against infections and other diseases.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

immunological adjuvant (IH-myoo-noh-LAH-jih-kul A-juh-vunt)

A substance used to help boost the immune response to a vaccine so that less vaccine is needed.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

KLH

A substance taken from a marine organism that may be linked to a specific antigen to boost the immune response to that antigen. KLH is being studied as a way to increase the immune response to cancer vaccines. It is a type of immune modulator. Also called keyhole limpet hemocyanin.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

neuroblastoma (NOOR-oh-blas-TOH-muh)

Cancer that arises in immature nerve cells and affects mostly infants and children.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

oral (OR-ul)

By or having to do with the mouth.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

phase I/II trial (fayz … TRY-ul)

A trial to study the safety, dosage levels, and response to a new treatment.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

remission (reh-MIH-shun)

A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

response (reh-SPONTS)

In medicine, an improvement related to treatment.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

trigger (TRIH-ger)

In medicine, a specific event that starts a process or that causes a particular outcome. For example, chemotherapy, painful treatments, or the smells, sounds, and sights that go with them may trigger anxiety and fear in a patient who has cancer. In allergies, exposure to mold, pollen or dust may trigger sneezing, watery eyes, and coughing.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

vaccine (vak-SEEN)

A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. A vaccine can help the body recognize and destroy cancer cells or microorganisms.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

vaccine adjuvant (vak-SEEN A-juh-vunt)

A substance added to a vaccine to improve the immune response so that less vaccine is needed.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

will (wil)

A legal document in which a person states what is to be done with his or her property after death, who is to carry out the terms of the will, and who is to care for any minor children.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)